Interventions for the treatment of nipple fissure: systematic review or randomized clinical trials

Abstract

Objective: to evaluate the efficacy and safety of different interventions for the treatment of nipple fissure. Methods: this systematic review, registered on the PROSPERO platform (under the number CRD42020170320), will follow the methodological recommendations of the Cochrane Handbook for Systematic Reviews of Interventions and the PRISMA statement for reporting quality. We will include randomized clinical trials (RCTs) with parallel or crossover designs, that analyzed any intervention (pharmacological and non-pharmacological) for the treatment of nipple fissures in lactating women. The primary outcomes analyzed will be a reduction of pain, improvement of the tissue healing process, and the reporting of adverse events related to interventions, such as allergy, discomfort, gastric and intestinal disorders, among others. A comprehensive search will be carried out in electronic databases and other sources. There will be no restriction on the date of publication and language. The methodological quality of the included RCTs will be assessed by the Cochrane bias risk tool. When possible (homogeneous studies and available data), the results of the studies will be pooled in a meta-analysis using the Review Manager 5.4 software, where the relative risk for dichotomous outcomes will be calculated, and the difference in means for continuous outcomes (confidence interval of 95%). The certainty of the body of evidence will be assessed according to the GRADE approach (Grading of Recommendations Assessment, Development, and Evaluation Working Group). (AU)